A Phase 2A Trial of DT402 for Autism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDefinium Therapeutics US, Inc.
About this trial
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)
Male or Female aged 18 to 65
Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66
Disqualifiers
Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking
First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
Any clinically significant unstable illness
Trial design
Design model
Single group
Treatments tested in this trial
DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
DrugA psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 200 mg DT402Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in 11-point Numerical Rating Scale (NRS) scores
The NRS is an 11-point PRO scale used to measure the severity or intensity of effects from 0 (no effect) to 10 (high severity or intensity of effect). It consists of various items related to both positive and negative effects in the autism patient population.
Time frame
Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15Secondary outcomes
1
Subjective 5-question Drug Effects Questionnaire (DEQ) scores
The Drug Effects Questionnaire is used in studies to assess the participant's acute subjective effects after ingesting substances. It consists of 5 PRO items. The analog scale of responses ranges from "not at all" to "extremely." The score is determined by the distance between the left anchor point and the participant's mark on the line. Each item is scored separately.
Time frame
1, 2, 4, 6, 8, and 24 hours post-dose2
Pharmacokinetic Plasma concentrations
Maximum Plasma Concentration \[Cmax\] of DT402 in the blood.
Time frame
pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose3
Pharmacokinetic Parameters (Cmax)
Maximum concentration (Cmax).
Time frame
pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose4
Pharmacokinetic Parameters (Tmax)
Time to maximum concentration (Tmax).
Time frame
pre-dose and 1, 2, 4, 6, 8, and 24 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov